Stents For Prosthetic Heart Valves

ABSTRACT

A stented valve prosthesis for implantation within a native mitral valve having a generally tubular expandable stent structure having a first end, a second end, a central body portion having one or more openings, and a longitudinal axis. A wing portion extends outwardly from the stent structure and away from the longitudinal axis of the stent structure in an expanded deployed configuration. A radius of the wing portion is greater than a radius of the central body portion in the expanded deployed configuration, and the wing portion fits within one of the openings in the central body portion of the stent structure in a crimped delivery configuration. A valve structure having a plurality of leaflets is attached to an interior of the stent structure.

CROSS-REFERENCE TO RELATED APPLICATION

The present application is a continuation of U.S. application Ser. No.12/321,760, filed Jan. 23, 2009 and titled “Stents For Prosthetic HeartValves”, which claims priority to U.S. Provisional Application Nos.61/062,207, filed Jan. 24, 2008, and titled “Delivery Systems andMethods of Implantation for Prosthetic Heart Valves”; and 61/075,902,filed Jun. 26, 2008 and titled “Heart Valve”; the entire contents ofwhich are incorporated herein by reference in their entireties.

TECHNICAL HELD

The present invention relates to prosthetic heart valves. Moreparticularly, it relates to devices, methods, and delivery systems forpercutaneously implanting prosthetic heart valves.

BACKGROUND

Diseased or otherwise deficient heart valves can be repaired or replacedusing a variety of different types of heart valve surgeries. Typicalheart valve surgeries involve an open-heart surgical procedure that isconducted under general anesthesia, during which the heart is stoppedwhile blood flow is controlled by a heart-lung bypass machine. This typeof valve surgery is highly invasive and exposes the patient to a numberof potentially serious risks, such as infection, stroke, renal failure,and adverse effects associated with use of the heart-lung machine, forexample.

Recently, there has been increasing interest in minimally invasive andpercutaneous replacement of cardiac valves. Such surgical techniquesinvolve making a very small opening in the skin of the patient intowhich a valve assembly is inserted in the body and delivered to theheart via a delivery device similar to a catheter. This technique isoften preferable to more invasive forms of surgery, such as theopen-heart surgical procedure described above. In the context ofpulmonary valve replacement, U.S. Patent Application Publication Nos.2003/0199971 A1 and 2003/0199963 A1, both filed by Tower, et al.,describe a valved segment of bovine jugular vein, mounted within anexpandable stent, for use as a replacement pulmonary valve. Thereplacement valve is mounted on a balloon catheter and deliveredpercutaneously via the vascular system to the location of the failedpulmonary valve and expanded by the balloon to compress the valveleaflets against the right ventricular outflow tract, anchoring andsealing the replacement valve. As described in the articles:“Percutaneous Insertion of the Pulmonary Valve”, Bonhoeffer, et al.,Journal of the American College of Cardiology 2002; 39: 1664-1669 and“Transcatheter Replacement of a Bovine Valve in Pulmonary Position”,Bonhoeffer, et al., Circulation 2000; 102; 813-816, the replacementpulmonary valve may be implanted to replace native pulmonary valves orprosthetic pulmonary valves located in valved conduits.

Various types and configurations of prosthetic heart valves are used inpercutaneous valve procedures to replace diseased natural human heartvalves. The actual shape and configuration of any particular prostheticheart valve is dependent to some extent upon the valve being replaced(i.e., mitral valve, tricuspid valve, aortic valve, or pulmonary valve).In general, the prosthetic heart valve designs attempt to replicate thefunction of the valve being replaced and thus will include valveleaflet-like structures used with either bioprostheses or mechanicalheart valve prostheses. In other words, the replacement valves mayinclude a valved vein segment that is mounted in some manner within anexpandable stent to make a stented valve. In order to prepare such avalve for percutaneous implantation, the stented valve can be initiallyprovided in an expanded or uncrimped condition, then crimped orcompressed around the balloon portion of a catheter until it is as closeto the diameter of the catheter as possible.

Other percutaneously-delivered prosthetic heart valves have beensuggested having a generally similar configuration, such as byBonhoeffer, P. et al., “Transcatheter Implantation of a Bovine Valve inPulmonary Position.” Circulation, 2002; 102:813-816, and by Cribier, A.et al. “Percutaneous Transcatheter Implantation of an Aortic ValveProsthesis for Calcific Aortic Stenosis.” Circulation, 2002;106:3006-3008, the disclosures of which are incorporated herein byreference. These techniques rely at least partially upon a frictionaltype of engagement between the expanded support structure and the nativetissue to maintain a position of the delivered prosthesis, although thestents can also become at least partially embedded in the surroundingtissue in response to the radial force provided by the stent andballoons used to expand the stent. Thus, with these transcathetertechniques, conventional sewing of the prosthetic heart valve to thepatient's native tissue is not necessary. Similarly, in an article byBonhoeffer, P. et al. titled “Percutaneous Insertion of the PulmonaryValve.” J Am Coll Cardiol, 2002; 39:1664-1669, the disclosure of whichis incorporated herein by reference, percutaneous delivery of abiological valve is described. The valve is sutured to an expandablestent within a previously implanted valved or non-valved conduit, or apreviously implanted valve. Again, radial expansion of the secondaryvalve stent is used for placing and maintaining the replacement valve.

Although there have been advances in percutaneous valve replacementtechniques and devices, there is a continued desire to provide differentdesigns of cardiac valves that can be implanted in a minimally invasiveand percutaneous manner. It is additionally desirable to provide valvesthat are resistant to migration after they are implanted.

SUMMARY

The replacement heart valves of the invention each include a stent towhich a valve structure is attached. The stents of the invention includea wide variety of structures and features that can be used alone or incombination with features of other stents of the invention. Many of thestructures are compressible to a relatively small diameter forpercutaneous delivery to the heart of the patient, and then areexpandable either via removal of external compressive forces (e.g.,self-expanding stents), or through application of an outward radialforce (e.g., balloon expandable stents). The devices delivered by thedelivery systems described herein can be used to deliver stents, valvedstents, or other interventional devices such as ASD (atrial septaldefect) closure devices, VSD (ventricular septal defect) closuredevices, or PFO (patent foramen ovate) occluders.

Methods for insertion of the replacement heart valves of the inventioninclude delivery systems that can maintain the stent structures in theircompressed state during their insertion and allow or cause the stentstructures to expand once they are in their desired location. Inaddition, delivery methods of the invention can include features thatallow the stents to be retrieved for removal or relocation thereof afterthey have been deployed or partially deployed from the stent deliverysystems. The methods may include implantation of the stent structuresusing either an antegrade or retrograde approach. Further, in many ofthe delivery approaches of the invention, the stent structure isrotatable in vivo to allow the stent structure to be positioned in adesired orientation.

The stent structures of the invention can provide resistance to leafletabrasion via the configuration of the wires or other structural elementsrelative to each other. Other stent structures can provide for reducedcrown density and various other configurations of wire shapes andfeatures for use with attached valves for valve replacement procedures.

BRIEF DESCRIPTION OF THE DRAWINGS

The present invention will be further explained with reference to theappended Figures, wherein like structure is referred to by like numeralsthroughout the several views, and wherein:

FIG. 1 is a front view of an embodiment of a stent in accordance withthe invention;

FIG. 2 is a front view of an embodiment of a stent in accordance withthe invention;

FIG. 3 is a front view of an embodiment of a stent in accordance withthe invention;

FIG. 4 is a perspective view of a stent embodiment in accordance withthe invention;

FIG. 5 is a top view of another stent embodiment;

FIG. 6 is a front view of another stent embodiment;

FIG. 7 is a front view of another stent embodiment;

FIG. 8 is a perspective view of another stent embodiment;

FIG. 9 is a perspective view of a stent embodiment having extendingelements and positioned on a mandrel;

FIG. 10 is a front view of an exemplary delivery system that can be usedfor delivering a stent of the type illustrated in FIG. 9;

FIG. 11-13 are enlarged front views of a portion of a delivery systemfor delivering a stent of the type shown in FIG. 9, including threesequential delivery steps;

FIG. 14 is a front schematic view of a stent positioned in an aorta;

FIGS. 15-18 are perspective views of different stent embodiments, eachpositioned within a heart vessel;

FIG. 19 is a front view of a stent embodiment;

FIG. 20 is a front view of a stent embodiment;

FIG. 21 is a top view of the stent of FIG. 20;

FIG. 22 is a schematic front view of the stent of FIG. 20 positioned ina heart vessel;

FIG. 23 is a front view of another stent embodiment;

FIG. 24 is a side view of the stent of FIG. 23;

FIG. 25 is a perspective view of the stent of FIG. 23, positioned on amandrel;

FIG. 26 is a top view of the stent of FIG. 23 positioned relative to aschematic view of a heart vessel, wherein the stent includes leaflets inits interior portion;

FIG. 27 is a top view of the stent of FIG. 23;

FIG. 28 is a perspective top view of the stent of FIG. 23 positioned ina heart;

FIG. 29 is a front view of another embodiment of a stent positioned on amandrel;

FIGS. 30 and 31 are front and perspective views respectively, of a solidmodel of a stent of the type illustrated in FIG. 29;

FIGS. 32 and 33 are front perspective views, respectively, of a stentembodiment;

FIGS. 34 and 35 are front views of a valved stent of the invention;

FIG. 36 is a schematic front view of a stent assembly being delivered toa heart valve;

FIG. 37 is a front view of a stent assembly positioned in a heart valve;

FIG. 38 is a front view of the stent assembly shown in FIGS. 36 and 37;

FIG. 39 is a front view of a stent assembly having a length L positionedin a heart vessel;

FIG. 40 is a top view of another stent embodiment positioned relative toa schematic view of an anatomical position in a heart;

FIG. 41 is a top view of another stent embodiment;

FIG. 42 is a top view of another stent positioned relative to theinterventricular septum and the mitral apparatus;

FIGS. 43-45 are perspective views of additional stent embodiments;

FIG. 46 is a front view of another stent embodiment;

FIGS. 47-50 are front schematic views of embodiments of stentspositioned in a heart vessel;

FIGS. 51-53 are front views of a different stents positioned relative toa portion of a heart valve that is cut-away for clarity; and

FIG. 54 is a top cross-sectional view of a valve attached within a stentframe.

DETAILED DESCRIPTION

As referred to herein, the prosthetic heart valves used in accordancewith various devices and methods of heart valve delivery may include awide variety of different configurations, such as a prosthetic heartvalve having tissue leaflets or a synthetic heart valve havingpolymeric, metallic, or tissue-engineered leaflets, and can bespecifically configured for replacing any heart valve. That is, whilemuch of the description herein refers to replacement of aortic valves,the prosthetic heart valves of the invention can also generally be usedfor replacement of native mitral, pulmonic, or tricuspid valves, for useas a venous valve, or to replace a failed bioprosthesis, such as in thearea of an aortic valve or mitral valve, for example.

Although each of the valves used with the delivery devices and methodsdescribed herein would typically include leaflets attached within aninterior area of a stent, the leaflets are not shown in many of theillustrated embodiments for clarity purposes. In general, the stentsdescribed herein include a support structure comprising a number ofstent or wire portions arranged relative to each other to provide adesired compressibility, strength, and leaflet attachment zone(s) to theheart valve. Other details on particular configurations of the stents ofthe invention are also described below; however, in general terms,stents of the invention are generally tubular support structures, andleaflets will be secured to the support structure to provide a valvedstent. The leaflets can be formed from a variety of materials, such asautologous tissue, xenogaph material, or synthetics as are known in theart. The leaflets may be provided as a homogenous, biological valvestructure, such as a porcine, bovine, or equine valve. Alternatively,the leaflets can be provided independent of one another (e.g., bovine orequine pericardial leaflets) and subsequently assembled to the supportstructure of the stent. In another alternative, the stent and leafletscan be fabricated at the same time, such as may be accomplished usinghigh strength nano-manufactured NiTi films of the type produced atAdvanced Bio Prosthetic Surfaces Ltd. (ABPS) of San Antonio, Tex., forexample. The support structures are generally configured to accommodatethree leaflets; however, the replacement prosthetic heart valves of theinvention can incorporate more or less than three leaflets.

In more general terms, the combination of a support structure with oneor more leaflets can assume a variety of other configurations thatdiffer from those shown and described, including any known prostheticheart valve design. In certain embodiments of the invention, the supportstructure with leaflets utilize certain features of known expandableprosthetic heart valve configurations, whether balloon expandable,self-expanding, or unfurling (as described, for example, in U.S. Pat.Nos. 3,671,979; 4,056,854; 4,994,077; 5,332,402; 5,370,685: 5,397,351;5,554,185; 5,855,601; and 6,168,614; U.S. Patent Application PublicationNo. 2004/0034411; Bonhoeffer P. et al., “Percutaneous Insertion of thePulmonary Valve”, Pediatric Cardiology, 2002; 39:1664-4669; Anderson HR, et al., “Transluminal Implantation of Artificial Heart Valves”, EURHeart J., 1992; 13;704-708; Anderson, J. R., et al., “TransluminalCatheter Implantation of New Expandable Artificial Cardiac Valve”, EURHeart J., 1990, 11: (Suppl) 224a; Hilbert S. L., “Evaluation ofExplained Polyurethane Trileaflet Cardiac Valve Prosthesis”, J ThoracCardiovascular Surgery, 1989; 94:419-29; Block P C, “Clinical andHemodynamic Follow-Up After Percutaneous Aortic Valvuloplasty in theElderly”, The American Journal of Cardiology, Vol. 62, Oct. 1, 1998;Boudjemline, Y., “Steps Toward Percutaneous Aortic Valve Replacement”,Circulation, 2002; 105:775-558; Bonhoeffer, P., “TranscatheterImplantation of a Bovine Valve in Pulmonary Position, a Lamb Study”,Circulation, 2000: 102:813-816; Boudjemline, Y., “PercutaneousImplantation of a Valve in the Descending Aorta In Lambs”, EUR Heart J,2002; 23:1045-1049; Kulkinski, D., “Future Horizons in Surgical AorticValve Replacement: Lessons Learned During the Early Stages of Developinga Transluminal Implantation Technique”, ASAIO J, 2004; 50:364-68; theteachings of which are all incorporated herein by reference).

Orientation and positioning of the stents of the invention may beaccomplished either by self-orientation of the stents (such as byinterference between features of the stent and a previously implantedstent or valve structure) or by manual orientation of the stent to alignits features with anatomical or previous bioprosthetic features, such ascan be accomplished using fluoroscopic visualization techniques, forexample. For example, when aligning the stents of the invention withnative anatomical structures, they should be aligned so as to not blockthe coronary arteries, and native mitral or tricuspid valves should bealigned relative to the anterior leaflet and/or thetrigones/commissures.

Some embodiments of the support structures of the stents describedherein can be a series of wires or wire segments arranged so that theyare capable of transitioning from a collapsed state to an expandedstate. In some embodiments, a number of individual wires comprising thesupport structure can be formed of a metal or other material. Thesewires are arranged in such a way that a support structure allows forfolding or compressing to a contracted state in which its internaldiameter is greatly reduced from its internal diameter in an expandedstate. In its collapsed state, such a support structure with attachedvalves can be mounted over a delivery device, such as a ballooncatheter, for example. The support structure is configured so that itcan be changed to its expanded state when desired, such as by theexpansion of a balloon catheter. The delivery systems used for such astent should be provided with degrees of rotational and axialorientation capabilities in order to properly position the new stent atits desired location.

The wires of the support structure of the stents in other embodimentscan alternatively be formed from a shape memory material such as anickel titanium alloy e.g., Nitinol) or a very high-tensile materialthat will expand to its original state after compression and removal ofexternal forces. With this material, the support structure isself-expandable from a contracted state to an expanded state, such as bythe application of heat, energy, and the like, or by the removal ofexternal forces (e.g., compressive forces). This support structure canbe repeatedly compressed and re-expanded without damaging the structureof the stent. In addition, the support structure of such an embodimentmay be laser cut from a single piece of material or may be assembledfrom a number of different components. For these types of stentstructures, one example of a delivery system that can be used includes acatheter with a retractable sheath that covers the stent until it is tobe deployed, at which point the sheath can be retracted to allow thestent to expand. Alternatively, the stent structures of the inventioncan be implanted using conventional surgical techniques and/or minimallyinvasive surgical procedures. In such cases, the stents of the inventioncan advantageously require relatively few or no sutures to secure thestent to an anatomical location within the patient.

Referring now to the Figures, wherein the components are labeled withlike numerals throughout the several Figures, and initially to FIGS. 1-5illustrate stents 10, 20, 30, and 40, respectively, each of which ispositioned over a mandrel. With particular reference to FIG. 1, stent 10includes a first end 12 having six crowns and a second end 14 havingtwelve crowns. Each of the stent crowns at the second end 14 includes aloop or eyelet 19 that can be used for attachment to a delivery systemand/or tissue valve, for example. It is contemplated that each of thecrowns at the second end includes a loop or eyelet 19, as shown, or thatonly some of the crowns include such a loop or eyelet. The size andshape of the loops 19 can all be the same on a single stent, or they canhave different sizes and/or shapes. Stent 10 further includes at leastone longitudinal post 16, which can be used for attachment of tissue tothe stent, along with providing additional stability to the first end 12of the stent. The longitudinal post 16 extends generally along theannular region of the stent 10 and has a height that accommodatesattachment of leaflet material. That is, the height of the post 16 isgenerally the same as the desired commissural height for the stent 10.As shown, the longitudinal posts 16 are comprised of two bars orvertical portions that are spaced from each other by a sufficientdistance to allow leaflets to be drawn between the vertical portions atthe leaflet commissures. Other skirt material portions and/or commissureprotection features can also be drawn through the space between thevertical portions. The space between the vertical portions of each post16 may have incremental steps 18, as shown in FIG. 1, which help toprovide anchoring points for suturing, for example, or the posts may notinclude such steps, as shown with post 132 in FIG. 3, which will bediscussed in farther detail below. If steps 18 are provided, they can begenerally perpendicular to the vertical posts, which will make theopenings generally rectangular in shape, or the steps can be differentlyoriented and shaped so that the openings are circular, elliptical, oranother chosen shape. It is further noted that the vertical portions ofthe posts 16 can be made of a different material or have a differentthickness than the rest of the stent wires and/or the posts can be madewith reinforced attachment stents or welds on the outflow end to provideadditional strength in this area.

With this stent 10, wire structure extends between one end of the post16 and the first end 12 (which may be referred to as the aortic aspectof the stent) and additional wire structure extends between the otherend of the stent post and the second end 14 (which may be referred to asthe ventricular aspect of the stent). The stent 10 may include onelongitudinal post 16 for each commissure of the valve that will beattached thereto, if desired. That is, for a three-leaflet valve, threelongitudinal posts 16 will be provided.

The stent 20 of FIG. 2 includes multiple wires that are arranged in agenerally similar configuration to that discussed above relative toFIG. 1. However, stent 20 further includes a central bulbous regionbetween its first and second ends 22, 24 that is larger in diameter thanthe diameters of the first and second ends of the stent. The bulbousregion can be configured to generally =ten the contours of the anatomywhere the stent will be positioned in the patient (e.g., at the aorticvalve sinus region). The first end 22 is flared inwardly (i.e., towardthe central axis of the stent), preferably by an amount that is enoughto be atraumatic, but not so pronounced that it loses contact with thepatient's anatomy or interferes with another device (e.g., a coronarycatheter) at a later date. Thus, the inward flare can be less than thatshown, although it is possible that the flare is even greater than thatshown. In addition, the second end 24 is slightly flared outwardly, asshown in the Figure. This flare at the second end 24 of the stent 20(i.e., away from the central longitudinal axis of the stent) can preventor minimize leakage between the implanted heart valve and the nativeannulus and/or to provide a physical and/or visual docking feature tosecure the stent against a wall of a vessel or opening in the heart toprevent migration of the stent, for example. Additionally, the secondend 24 can also have an at least slightly inward bend (see FIG. 3, forexample) that may be advantageous when implanting this stent in theaortic region in order to minimize trauma to adjacent anatomicalstructures (e.g., the mitral valve anterior leaflet or the leftventricular wall). This slight inward bend can also help to minimizepressure on the septum in the area of the bundle branch, which can inturn reduce the potential for arrhythmias or heart block during or afterthe transcatheter valve replacement procedure.

FIGS. 3 and 4 illustrate stents 30 end 40 that are “selectively” flaredto match particular desired shapes for portions of the stent. Forexample, certain stent wires are flared outwardly to avoid potentialinterference between the stent and the tissue leaflets of thereplacement valves. The stent features to which the tissue will beattached may not be flared at all, such that the stent is relativelytubular, or these wires could instead be flared inwardly or outwardly.Stents 30, 40 include central regions 34, 44, respectively that aresomewhat larger in diameter than the adjacent portions of the stent. Thestent 30 further includes at least one longitudinal element or featurethat can be used for attachment of tissue to the stent, such as alongitudinal post 32. Such posts 32 can also be positioned at the samedistance from the longitudinal axis as the other stent elements in thecentral region 34, or the longitudinal posts can be closer to or furtherfrom the central axis of the stent than the other stent elements in thecentral region 34, if desired. By positioning the posts closer to thecentral axis than the other wires in the central region 34, the freeedges of the dynamic leaflets positioned inside the stent 30, 40 of thenew or replacement valve would be less likely to contact the stent postswhen the valve leaflets are fully open. This reduced contact can reducethe potential for wear on the leaflets during valve cycling. Anadditional benefit of positioning the wires of the post closer to thecentral longitudinal axis as the other stent wires is to minimize stressat the commissures, and to help maintain coronary perfusion. This can beaccomplished by limiting the opening of the leaflet so that coronaryflow behind the valve leaflets is maintained. Yet another benefit ofthese configurations having attachment points that are inwardly offsetfrom the largest outer diameter of the stent is that a smaller tissuevalve can be used, which in turn reduces the overall transcatheter crimpprofile of the delivery system.

Reduction of the potential wear on the valve leaflets can alternativelybe accomplished by fastening leaflet commissures closer to the center ofthe stent than to the outer circumference. FIG. 54 illustrates such anarrangement with a schematic view of an outer stent frame 400 havingthree leaflets 402 arranged so that each two adjacent leaflets areattached to the stent frame 400 at a leaflet commissure area 404.Another fastening point of each of these sets of leaflets 402 at thecommissure area 404 is shifted inwardly toward the center of the stentframe 400 to an inner fastening point 406. In this way, when theleaflets 402 are open, their free edges can only move out as far as thecircle or inner area 408, which is shown schematically with a brokenline. As shown, even if the leaflets 402 are in this fully openposition, they will not contact the outer stent frame 400, therebyreducing potential wear on the valve leaflets.

Stents 10, 20, and 40 each include an arrangement of wires that providestwelve stent crowns at one end and six stent crowns at the opposite end,while stent 30 includes twelve crowns at both ends. For embodiments thatinclude twelve crowns at the inflow end of the steal, this configurationcan provide additional strength to the stent annulus area to preventmigration, to open stenotic native valve orifices, and also to provide agreater number of points for attaching pericardial leaflets to thestent. it is possible, however, to provide less than twelve (e.g., six)crowns at the outflow because the same stent strength is not required atthis end for less tissue attachment points are needed. These illustratedstents are only some of the arrangements of wires that can achieve thisfeature of having different numbers of steal crowns at opposite ends ofa single stent. In a further alternative, each of the ends of one stentcan have the same number of stent crowns, but the center portion canhave a more or less dense concentration of wires than either of theends. In any case, a stent having less stent crowns at one of its endsmay simplify the use of an associated delivery system, since the endwith less stent crowns will have a corresponding smaller number ofcrowns that need to be connected to the delivery system.

FIGS. 5-8 illustrate additional stent embodiments 80, 60, 70. Stent 60has a similar shape to the stent 20 of FIG. 2; however, stent 60includes the same number of stent crowns at both ends, and also does nothave the same longitudinal posts that are part of the wire arrangementof stent 20. Rather, stent 60 includes a generally regular diagonalcrisscross wire pattern along its entire length, and further includesmultiple eyelets or hooks 62 at one end. A first stent end 64 is flaredgenerally inwardly and a second spent end 66 is contoured both inwardlyand outwardly as compared to the central region of the stent. Stent 70includes a bulbous shape to the wires at one end, eyelets or hoops atthe opposite end, and differing numbers of stent crowns at the oppositeends of the stent. Stent 80 includes pocket portions 82 that provideattachment points for the leaflets 84 that are positioned inwardly fromthe outer diameter of the stent 80. Again, these inwardly locatedattachment points will reduce the potential for leaflet abrasion andmoves the commissure attachment points to an area that that puts lessstress on the leaflets. Finally, the pockets 82 provide an area wherethe suture knots can be positioned so that they do not increase theoverall crimp profile of the valve.

FIG. 9 illustrates another stent embodiment 90 that includes severalfeatures described above relative to stent crowns, longitudinal posts,incremental steps on at least one of the posts and the wire. Stent 90also includes at least one longitudinal stent post 92 comprised of twovertical bars speed from each other. Stent 90 further includes threewings 94, each of which extends outwardly from the stent body andbetween two longitudinal posts 92. The longitudinal posts 92 can bepositioned inwardly of the outer diameter of the stent 90 to provide theadvantages discussed above relative to avoiding leaflet abrasion and thelike. These wings can be used to dock the stent against the top aspectof the native leaflets when the stent is implanted. Again, this stenthas differing numbers of crowns at its opposite ends, and hooks oreyelets on the crowns at one end.

FIGS. 10-13 illustrate a portion of one exemplary delivery system 100for delivering a stent having wings, such as stent 90. In particular,FIG. 10 shows a delivery system tip including a fully crimped stentenclosed within a main catheter sheath. FIG. 11 shows the wings 94 beingdeployed from the delivery system 100 by retracting the main cathetersheath 102. In an implantation, the wings 94 can be positioned tointerface with the outflow aspect of the native valve leaflets. Oncethese wings 94 are in contact with the native valve leaflets, the inflowor annular end of the stent is deployed by driving the catheter tipforward, as illustrated in FIG. 12. The native leaflets will now contactthe wings 94 and inflow end of the stent 90, thereby minimizing thepotential for migration of the replacement valve. The outflow end of thestent can now be deployed, as shown in FIG. 13, to fully re-expand thestent 90 release it from the delivery system, which is accomplished byfurther retracting the main catheter sheath.

FIG. 14 illustrates a stent 110 that includes a highly flexible deliverysystem attachment end 112 that enables the portion of the stent 110 thatinterfaces with the anatomy to create secure fixation to be fullydeployed while still attached to the delivery system. This systemenables a sprocket-style delivery system attachment mechanism that canhelp to minimize the delivery system diameter size. A sprocket-styledelivery system includes some type of inner core member from whichmultiple protrusions extend, where the shape of the protrusions allowfor engagement with wires of a stent. Stent 110 does not requireattachment of each crown on the aortic end of the stent, while stillenabling the ventricular region of the stent to fully deploy to assessfunctionality and positioning, which can thereby allow for a smallerdiameter for the delivery system. As shown, stent 110 is positionedrelative to an aorta 114, and stent 110 includes an outflow end that hasvery flexible struts that enable the anchoring portion of the stent tobe fully deployed to assess the valve functionality and positioning,while still being captured on a sprocket-style delivery system. Theouter diameter of the stent can preferably expand to match the maximuminner diameter of the anchoring region.

FIG. 15 illustrates another embodiment of a stent 120 having a centralregion 122 with a diameter that is larger than the diameter at either ofthe ends. A first end 124 has six stent crowns, while the oppositesecond end 126 has twelve stent crowns, each of which includes an eyelet128. With such an arrangement, the number of crowns provided at theoutflow end of the stent is reduced, thereby requiring fewer points forattachment to a delivery system. FIG. 16 illustrates another stentembodiment 130 including flared regions at both ends and a centralregion that is generally cylindrical.

FIG. 17 illustrates another embodiment of a stent 140 that is positionedat the aortic valve position of a heart. Stent 140 includes six stentcrowns at one end and twelve stent crowns at the opposite end, andfurther includes a central area with a relatively large opening or gap142 between the wires. The gap 142 can be positioned at the coronaryostia so as to not obstruct or interfere with blood flow. The stents120, 130, 140, along with many of the other stent embodiments describedherein, are designed to match with native anatomic features of a patientto improve resistance to migration and improve paravalvular replacementvalve sealing.

FIG. 18 illustrates another embodiment of a stent 150 that is designedfor anatomic compatibility and includes a bulbous portion that ispositioned to sit generally at the annular area of a vessel. A ring 152shown in this figure is a sealing gasket on the outside of the stent andis positioned generally at the annulus of a vessel when implanted. Thegasket can be made of fabric or inflatable tube structures, for example.

FIG. 19 illustrates a stent 160 that does not include many of thecontours described relative to other stent embodiments of the invention,but includes longitudinal posts 162 for attachment of the valve tissue.Posts 162 are comprised of two longitudinal wire portions 166 spacedfrom each other, and further include optional intermediate members 168that extend between the longitudinal portions 166. The outer structurering structure shown in this drawing is provided as an illustration ofthe general stitching path that can be used for tissue material withinthe stent.

FIGS. 20-22 illustrate an embodiment of a stent 180 that includes anumber of features described above for the stents of the invention,along with additional features. In particular, FIG. 20 shows the stent180 with longitudinal posts 182 extending in the direction of the lengthof the stent 180, and a region 184 at one end that is bulbous or has alarger diameter than the central portion of the stent. The opposite endof the stent 180 includes flared portions 186 that extend from oppositesides of the generally tubular central portion. As shown in FIG. 21,each flared portion 186 can include two crowns, although it is possiblethat the flared portion 186 can be configured somewhat differently thanshown (e.g., there can be more or less crowns, the crowns can be shapeddifferently, the flared portion 186 can extend around a larger orsmaller portion of the circumference of the stent, and the like). As isfurther illustrated in FIG. 20, the geometry of the stent can bedesigned to incorporate optimal attachment points for tissue. That is,the stent node trajectory can be specifically selected to provide thedesired points for the attachment of tissue. Such a feature can beconsidered and designed for tents including longitudinal posts, as shownin FIG. 20, and may also be considered for stents comprising morediamond-shaped wire patterns without longitudinal posts.

The outer profile of stent 180 is shown in an exemplary position withinthe anatomy (i.e., aorta) of a patient in FIG. 22, with the central areathat includes the commissural posts being positioned in the bulbous areaof an aorta. The flares 186 extend into the ventricle in order to helpanchor the stent 180 in place. The flares 186 are preferably positionedin locations where they do not disrupt the native anatomical function.That is, the flares 186 should not interfere with the mitral valveanterior leaflet and should not apply pressure to the septum in the areaof the conduction system bundle branch. Again, it is also preferablethat the central portion of the stent 180 does not contact the nativeaortic sinus region, in order to minimize the potential for coronaryocclusion or obstruction.

It is noted that in many of the stent embodiments shown and describedherein, the aspect ratio of certain portions of the stent is exemplary,and can be somewhat different from that shown. It is further noted thatif the stent of any of the embodiments is to be positioned to replacethe aortic valve, the stent can be provided with a lower density wireportion in the area where the coronaries are located. To eliminate theneed to clock the device, reduced wire density around the entireperimeter of the stent in the central area can be provided. Further,stent embodiments described herein may be Modified to include additionalstructure for attachment of tissue for the valve, such as the verticalstent posts described in many of the embodiments.

FIGS. 21-28 illustrate another embodiment of a stent 200 that includes acentral cylindrical portion with at least two regions with a lowerdensity of wires, each of which is provided for positioning in the areaof the coronary openings. The wires of this lower density area arearranged to provide openings 202 that are larger than the spaces betweenother wires of the stent. These openings are offset along the length ofthe stent to be arranged in a zigzag type of pattern around thecircumference of the stent 120. One end of the stent 200 includes flaredportions 204 that extend from opposite sides of the central cylindricalportion of the stent. Each flared portion 204 includes three crowns,although variations of this configuration are contemplated, as discussedabove relative to flared stent portions. As shown in FIG. 26, stent 200is positioned relative to a mitral valve 210 so that one of the flaredportions is positioned at the left ventricle, and one of the openings inthe stent is positioned at the left coronary artery. FIG. 27 is a topview of the stent 190, and FIG. 28 shows one exemplary position of thestent 190 relative to the anatomy of a patient, including the septum andanterior leaflet of the mitral valve.

FIG. 29 illustrates a stent 220 that includes openings 222 (i.e., areasof lower wire density) for the coronaries, and further includessub-annular and supra-annular circumferential wings to help secure thestent to the patient's native anatomy. In particular, the area below theopenings 222 includes an outward curve or flare to create a wing 224that can extend around all or part of the circumference of the stent220. The wires then curve back toward the central longitudinal axis ofthe stent, then curve or flare outwardly again to create a wing 226 thatcan extend around all or a part of the circumference of the stent 220.As shown, the wings 224, 226 and the area between them form a generallysinusoidal configuration, where the wing 224 can be positioned above anannulus and wing 226 can be positioned below that annulus to provide theanchoring for a more secure attachment in that position. This series ofwings can help to anchor the stent in regions of calcified or fusedleaflets in the aortic stenosis patient population. Stent 220 furtherincludes imaging markers 228 that can be used to identify the high andlow points of the commissures, the annular (valve) plane of the implant,and/or other features. Markers can also be used to identify high and lowboundaries for optimal implant placement within the patient's anatomy.

FIGS. 30 and 31 are solid models of a stent 240 that is configuredsimilarly to the stent of FIG. 29, including the sinusoidal shape at oneend that creates wing areas. These wings can have a different profilefrom that shown, although it is preferable in this embodiment that thereare sinusoidal “peaks” 242, 244 that are separated by a “valley” 246,where the annulus of a valve can be positioned in the valley 246 so thatthe peaks 242, 244 are on opposite sides of the annulus. The peaks andvalleys can have different heights than shown, and the spacing betweenthe peaks may also be different. That is, the spacing between thesub-annular and supra-annular flares can be varied, depending on thespecific procedure that will be performed and the desiredcharacteristics of the stent. These embodiments, along with other shapedstents described herein, can help to minimize stent migration within thepatient due to the ability of the stent to conform to various contoursof the patient's anatomy. FIG. 30 also illustrates an optional groove248 that can be positioned generally around the periphery of the stent240 to match the native 3-dimensional configuration of the nativeanatomy. A gasket 250 can be positioned within the groove 248, wheresuch a gasket 250 can include one continuous structure that generallyfollows the shape of the groove 248, or it can include one or morepieces within portions of the groove 248. The gasket 250 can improveparavalvular sealing. Further, the gasket 250 can be made of a materialthat can heal into the native tissue of the patient, which can help thestent to resist migration.

FIGS. 32 and 33 illustrate another stent embodiment 240 that includesflares at both the sub-annular and sinotubular junction (STJ) areas. Theillustrated stent further includes vertical stent posts, twelve inflowcrowns and six outflow crowns although there could be more or less thanthese numbers of inflow and outflow crowns. Stent 240 has a wirearrangement similar to that shown for the stents of FIGS. 1-4 and otherstents described and shown herein; however, the central area of stent240 is more tubular or “straight,” with slightly curved areas at bothends.

One exemplary stent of the invention combines the following features:eyelets at one end for attachment to the delivery system and tissuevalve; vertical commissural tissue attach stents or posts; moderatelyflared non-commissural attach vertical stents or STJ flare; sub-annularflares; inflow and outflow atraumatic curvatures; a twelve crown inflow;and six tapered crowns at the outflow end. Such an embodiment of a stentis illustrated, for example, as stent 250 in FIGS. 34 and 35. Stent 250further includes tissue material 252 attached within its internal areato provide leaflets for the valve. Two spaced-apart vertical members areused to make up vertical posts 254, one of which is most visible in FIG.35. One exemplary pattern for stitching the tissue to the vertical post254 is also illustrated, although the stitching pattern can differ fromthat shown.

Delivering any balloon-expandable stents of the invention to theimplantation location can be performed percutaneously. In general terms,this includes providing a transcatheter assembly, including a deliverycatheter, a balloon catheter, and a guide wire. Some delivery cathetersof this type are known in the art, and define a lumen within which theballoon catheter is received. The balloon catheter, in turn, defines alumen within which the guide wire is slideably disposed. Further, theballoon catheter includes a balloon that is fluidly connected to aninflation source. It is noted that if the stent being implanted is theself-expanding type of stent, the balloon would not be needed and asheath or other restraining means would be used for maintaining thestent in its compressed state until deployment of the stent, asdescribed herein. In any case, for a balloon-expandable stent, thetranscatheter assembly is appropriately sized for a desired percutaneousapproach to the implantation location, For example, the transcatheterassembly can be sized for delivery to the heart valve via an opening ata carotid artery, a jugular vein, a sub-clavian vein, femoral artery orvein, or the like. Essentially, any percutaneous intercostalspenetration can be made to facilitate use of the transcatheter assembly.

Prior to delivery, the stent is mounted over the balloon in a contractedstate to be as small as possible without causing permanent deformationof the stent structure. As compared to the expanded state, the supportstructure is compressed onto itself and the balloon, thus defining adecreased inner diameter as compared to an inner diameter in theexpanded state. While this description is related to the delivery of aballoon-expandable stent, the same basic procedures can also beapplicable to a self-expanding stent, where the delivery system wouldnot include a balloon, but would preferably include a sheath or someother type of configuration for maintaining the stent in a compressedcondition until its deployment.

With the stent mounted to the balloon, the transcatheter assembly isdelivered through a percutaneous opening (not shown) in the patient viathe delivery catheter. The implantation location is located by insertingthe guide wire into the patient, which guide wire extends from a distalend of the delivery catheter, with the balloon catheter otherwiseretracted within the delivery catheter. The balloon catheter is thenadvanced distally from the delivery catheter along the guide wire, withthe balloon and stent positioned relative to the implantation location.In an alternative embodiment, the stent is delivered to an implantationlocation via a minimally invasive surgical incision (i.e.,non-percutaneously). In another alternative embodiment, the stent isdelivered via open heart/chest surgery. In one embodiment of the stentsof the invention, the stent includes a radiopaque, echogenic, or MRIvisible material to facilitate visual confirmation of proper placementof the stent. Alternatively, other known surgical visual aids can beincorporated into the stent. The techniques described relative toplacement of the stent within the heart can be used both to monitor andcorrect the placement of the stent in a longitudinal direction relativeto the length of the anatomical structure in which it is positioned.

Once the stent is properly positioned, the balloon catheter is operatedto inflate the balloon, thus transitioning the skin to an expandedstate. Alternatively, where the support structure is formed of a shapememory material, the stent can self-expand to its expanded state.

One or more markers on the valve, along with a corresponding imagingsystem (e.g., echo, MRI, etc.) can be used with the variousrepositionable delivery systems described herein in order to verify theproper placement of the valve prior to releasing it from the deliverysystem. A number of factors can be considered, alone or in combination,to verify that the valve is properly placed in an implantation site,where some exemplary factors are as follows: (1) lack of paravalvularleakage around the replacement valve, which can be advantageouslyexamined while blood is flowing through the valve since these deliverysystems allow for flow through and around the valve; (2) optimalrotational orientation of the replacement valve relative to the coronaryarteries; (3) the presence of coronary flow with the replacement valvein place; (4) correct longitudinal alignment of the replacement valveannulus with respect to the native patient anatomy; (5) verificationthat the position of the sinus region of the replacement valve does notinterfere with native coronary flow; (6) verification that the sealingskirt is aligned with anatomical features to minimize paravalvularleakage; (7) verification that the replacement valve does not inducearrhythmias prior to final release; and (8) verification that thereplacement valve does not interfere with function of an adjacent valve,such as the mitral valve.

FIGS. 36-39 are schematic views of various embodiments of stents of thepresent invention. In particular, FIG. 36 illustrates a stent assembly280 that includes features that align and secure it with specificanatomical features in the left ventricle region and the leftventricular outflow tract region of a patient. Stent assembly 280includes a stented valve 282 from which tethers 284 extend. Tethers 284are preferably flexible to accommodate curvature of the native aortaabove the valve annulus. Optional anchors 286 are shown at the distalends of the stent. More specifically, each of the tethers 284 extendsfrom one of the commissures 288 of the stent 282. The stent assembly 280further includes a distal element such as a stent graft 290 positionedbetween the tethers 284 near the anchors 286, which is flexible and canaccommodate widely varying patient anatomy. The stent graft 290 will bepositioned distal to the sinus area of the left ventricular outflowtract when implanted. This configuration can facilitate stabilization ofthe stent assembly and may be designed to register or interface withanother stent gait that is implanted at a later time.

This stent assembly 280 can include flexible connections between annularand supra-annular stent aspects. The flexible connections may beelastomeric, fabric, metal, or the like. Such flexible connections canhelp the stent assembly to accommodate most varying anatomy above thesinotubular junction and also to accommodate aortic curvature. Inaddition, the flexible connections can make the stent assembly able toaccommodate anerysmal aortas.

The stent assembly 280 may further include a gasket 294 positionedadjacent an end of the steeled valve 282. In addition, when the stentassembly is implanted in a patient, a plaque pocket 296 can be createdthat provides embolic protection by creating a volume that can entrapplaque, calcification, and other embolic from traveling in a distaldirection and causing a thromembolic event, such as a stroke.

Alternatively, portions of the system may be designed to include alonger useful life than others. For example, the frame of the presentinvention could be designed to have a relatively long useful life (e.g.20 years), while the tissue component could have a relatively shorteruseful life (e.g. 10 years).

An embolic protection device 292 can be provided distal to the stentassembly 280, as is shown in FIG. 36. The device 292 can be utilizedduring the implantation procedure to capture and trap any embolireleased and/or generated by the valve procedure, while stillmaintaining uninhibited or sufficient perfusion through the aorta andcoronary arteries during valve implantation. In addition, FIGS. 36-39illustrate a portion of the stent positioned above the sinotubularjunction 284 covered with fabric, polymer, and/or tissue, which canserve this same purpose.

FIGS. 37-39 illustrate alternative views of the stent assembly 280, bothwithin a heart vessel and independent of anatomical structure (FIG. 38).It is noted that the anchoring of the stent posts via the anchors 286can help to prevent valve ejection. FIG. 37 shows the stent assembly 280implanted in a supra-annular position in a patient's anatomy, which canbeneficially improve the orifice area by avoiding the stenotic region ofthe aorta. FIG. 39 shows the flexibility of the stent graft material inorder to conform to the curved area of an aorta.

FIG. 40 illustrates a top view of a stent 300 having a fixation tab 302positioned in the non-coronary sinus area 310, and with no such tabs ateither the right coronary artery 314 or the left coronary artery 312.That is, fixation components of stent 300 may secure the system tonon-coronary sinus and/or regions of the left ventricle adjacent to theaortic valve annulus. This may avoid obstruction of coronary blood flowand prevent unwanted interaction between the system and the septum andmitral valve anterior leaflet. Further, the fixation tab 302 does notprevent or inhibit subsequent coronary intervention, while providing theadvantage of minimizing or preventing migration of the stent toward theaorta. FIG. 41 illustrates a stent having both a fixation tab 302 andflared portions 304 that help to prevent migration of the stent. FIG. 42illustrates stent 300 having flared regions 304 as positioned relativeto the interventricular septum 306 and the mitral valve apparatus 308.

FIGS. 43-45 illustrate alternative stent embodiments 360, 370, 380, eachof which comprises an extending or fixation tab 364, 374, 384,respectively, along with flared portions 362, 372, 382, respectively.Tab 364 of stent 360 is configured as a bulging wire area, tab 374 ofstent 370 comprises an extension that is angled in the same generaldirection as the wings 372, and tab 384 of stent 380 comprises anextension that is angled in generally the opposite direction from thatof the wings 382. The stent 370 is illustrated in FIG. 51 with its tab374 positioned relative to a non-coronary sinus 376, stent 380 isillustrated in FIG. 52 with its tab 384 positioned relative to anon-coronary sinus 386, and stent 360 is illustrated in FIG. 53 with itsfixation tab 364 positioned relative to a non-coronary sinus 366. Asshown, these tabs can help to prevent stent migration due to theirinterference with the patient's anatomy.

FIGS. 47 and 48 schematically illustrate the aorta of a patient. Asshown, the aorta begins to curve distal to the annulus level. Manytypical transcatheter valve stents are cylindrical with a relativelystraight axis. Such a stent structure does not easily conform to thenative anatomy, which can present a number of potential issues. First,the reduced. pressure on the anatomy at the inner portion of thecurvature (such as is illustrated with the an area 332 adjacent to astent 330 in FIG. 49) can lead to improper seating, migration, and/orparavalvular leakage. Second, increased pressure on the anatomy at theouter portion of the curvature can lead to, or increase the potentialfor cardiac conduction system block or interference. Third, increasedpressure on the anatomy at the outer portion of the curvature can leadto local erosion, irritation, and/or dissection of tissue. Fourth, thestent can be subjected to increased torsional and/or bending stressesand strains, which can affect the short-term structural integrity of thestent. Finally, lack of conformity with the curvature of the nativeanatomy can inhibit the ability of the clinician to accurately orconsistently position the stent/valve in the desired location.

Several stents of the present invention can alleviate thisnon-conformity of the valve frame with the native anatomy. In oneembodiment, the stent could have a predetermined curvature that matchesor more closely conforms to the native anatomy, such as stent 335 inFIG. 50. In other embodiments, the stent could have flexibility (e.g.,area 322 of stent 320 in FIGS. 47-48) or a binged area (e.g., hinge 342of stent 340 in FIG. 48) in the portion of the stent that would enableit to conform to the native curved anatomy. FIGS. 46 and 47 illustratestent designs that incorporate flexibility in their central regions,which in turn enables improved conformity with the native anatomy. Thecentral areas or numbers 322 can be fabricated from a wide variety ofmaterials, such as metals, polymers, fabrics, and the like. The members322 can include a number of geometries that allow flexibility to conformto the native, curved aortic anatomy. Referring again to FIG. 36, thisstent assembly incorporates elements 287 that are not attached to eachother except through flexible materials such as fabric, tissue, orpolymeric materials that enable a high degree of conformity with thenative anatomy curvature within the ascending aorta.

The present invention also optionally or alternatively includes distalemboli protection features which may be incorporated into a deliverysystem for delivering a stent assembly (e.g. in the nose assembly), suchas the thromboembolic filter. The protection features may provide acuteprotection during percutaneous valve delivery. The protection featuresmay afford substantially uninhibited flow through coronaries duringsystole or diastole.

The present invention has now been described with reference to severalembodiments thereof. The entire disclosure of any patent or patentapplication identified herein is hereby incorporated by reference. Theforegoing detailed description and examples have been given for clarityof understanding only. No unnecessary limitations are to be understoodtherefrom. It will be apparent to those skilled in the art that manychanges can be made in the embodiments described without departing fromthe scope of the invention. Thus, the scope of the present inventionshould not be limited to the structures described herein, but only bythe structures described by the language of the claims and theequivalents of those structures.

1.-23. (canceled)
 24. A stented valve prosthesis for implantation withina native mitral valve, comprising: a generally tubular expandable stentstructure comprising a first end, a second end, a central body portionhaving one or more openings, and a longitudinal axis; a wing portionextending outwardly from the stent structure and away from thelongitudinal axis of the stent structure in an expanded deployedconfiguration, wherein a radius of the wing portion is greater than aradius of the central body portion in the expanded deployedconfiguration, and wherein the wing portion fits within one of theopenings in the central body portion of the stent structure in a crimpeddelivery configuration; and a valve structure comprising a plurality ofleaflets attached to an interior of the stent structure.
 25. The stentedvalve prosthesis of claim 24, wherein the wing portion comprises adistal end detached from the stent structure.
 26. The stented valveprosthesis of claim 24, wherein the wing portion extends from the firstend of the stent structure and toward the second end of the stentstructure.
 27. The stented valve prosthesis of claim 24, wherein thesecond end of the stent structure comprises a flared portion haying aradius greater than the radius of the central body portion.
 28. Thestented valve prosthesis of claim 24, wherein the wing portion extendsaround a majority of a circumference of the first end of the stentstructure.
 29. The stented valve prosthesis of claim 24, wherein thewing portion extends toward the first end of the stent structure. 30.The stented valve prosthesis of claim 24, wherein the wing portioncomprises a curve.
 31. The stented valve prosthesis of claim 30, whereinthe wing portion curves back toward the longitudinal axis of the stentstructure.
 32. The stented valve prosthesis of claim 24, wherein thewing portion is configured to engage an annulus of the native mitralvalve.
 33. The stented valve prosthesis of claim 24, further comprisinga sealing gasket attached to the stent structure.
 34. The stented valveprosthesis of claim 24, wherein the stent structure is self-expanding.35. The stented valve prosthesis of claim 24, wherein the wing portioncomprises a plurality of wing components.
 36. A stented valve prosthesisfor implantation within a native mitral valve, comprising: a generallytubular stent structure comprising a first end, a second end, a centralbody portion, and a longitudinal axis; a wing portion extendingoutwardly from the first end of the stent structure toward the secondend of the stent structure and away from the longitudinal axis of thestent structure over an area of reduced wire density of the stentstructure, wherein a radius of the wing portion is greater than a radiusof the central body portion; and a valve structure comprising aplurality of leaflets attached to an interior of the stent structure.37. The stented valve prosthesis of claim 36, wherein the area ofreduced wire density is located in the central body portion of the stentstructure.
 38. The stented valve prosthesis of claim 36, wherein adiameter of the second end of the stent structure is greater than adiameter of the central body portion.
 39. The stented valve prosthesisof claim 36, wherein the wing portion comprises a plurality of wingcomponents.
 40. A method of implanting a stented valve prosthesis withina native mitral valve, comprising: inserting a delivery system with thestented valve prosthesis into a body lumen, the stented valve prosthesiscomprising: a generally tubular expandable stent structure comprising afirst end, a second end, a central body portion having one or moreopenings, and a longitudinal axis; a wing portion extending outwardlyfrom the stent structure and away from the longitudinal axis of thestent structure in an expanded deployed configuration, wherein a radiusof the wing portion is greater than a radius of the central body portionin the expanded deployed configuration, and wherein the wing portion itswithin one of the openings in the central body portion of the stentstructure in a crimped delivery configuration; and a valve structurecomprising a plurality of leaflets attached to an interior of the stentstructure; and deploying the stented valve prosthesis at an implantationlocation within the native mitral valve.
 41. The method of claim 40,wherein deploying the stented valve prosthesis comprises positioning thestented valve prosthesis such that the wing portion of the stentstructure engages a mitral valve annulus on an atrial side of the nativemitral valve, the central body portion of the stent structure is locatedwithin the native mitral valve annulus, and the second end of thestented valve prosthesis is located on a ventricular side of the nativemitral valve.
 42. The method of claim 40, wherein inserting the deliverysystem into the body lumen comprises percutaneously advancing thedelivery system to the native mitral valve via a catheterizationtechnique.
 43. The method of claim 40, further comprising removing thedelivery system from the body lumen after deploying the stented valveprosthesis.